Tag Archive for: leriglitazone

NEZGLYAL® (leriglitazone) receives a positive CHMP opinion for the treatment of cerebral Adrenoleukodystrophy (cALD), a rare neurodegenerative disease

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Recommendation based on NEXUS data; Minoryx and Neuraxpharm expect European Commission approval by the end of this quarter Barcelona, Spain and Düsseldorf, Germany – 24 July, 2026 – Minoryx Therapeutics and Neuraxpharm Group, announce that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation approval under exceptional […]

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Leriglitazone Marketing Authorization Application submitted for treatment of cerebral adrenoleukodystrophy has been validated by European Medicines Agency

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Barcelona, Spain and Düsseldorf, Germany – 23 July 2025 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, today announce that the Marketing Authorization Application (MAA) for Minoryx’s […]

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Leriglitazone has met the primary endpoint in NEXUS, the pivotal trial for pediatric patients with cerebral Adrenoleukodystrophy

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Statistically significant difference in arrested disease in leriglitazone treated patients when compared to the natural history of the disease Submission of European marketing authorization application (MAA) for leriglitazone expected mid-2025. Barcelona, Spain and Düsseldorf, Germany – 11 December 2024 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous […]

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Update on Regulatory Review of leriglitazone in the EU

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A re-examination for cerebral adrenoleukodystrophy (cALD) will be requested following a negative CHMP opinion Barcelona, Spain and Düsseldorf, Germany – 26 January, 2024 – Minoryx Therapeutics, a late stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused […]

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